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PDA Response to FDA Revised Draft Guidance on Quality Metrics 27 Mar 2017 (pdf)

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FDA Draft Guidance on Media Fills for Validation of Aseptic Preparations for PET Drugs 23 Dec 2011 (pdf)

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EU Good Distribution Practice of Medicinal Products for Human Use 17 Jul 2014 (pdf)

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PI 041-1 (Draft 3) Guidance on Data Integrity (pdf)

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May 2002 PDA Southeast Chapter Newsletter (pdf)

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